MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X27IN 1 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPP40D
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what tissue was being approximated or sutured when it broke? unknown.What was used to complete the procedure? unknown.Please provide the lot number for the involved device.Lot# qkmmck.Please provide the procedure name.Unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified." trade name - irgacare "active ingredient(s)  triclosan " dosage form suture/solid/parenteral " strength = 472 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the suture was breaking and not coming out of the dispenser properly.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 8X27IN 1 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11793967
• Report Number: 2210968-2021-04353
• Device Sequence Number: 4203527
• Product Code: GAM
• UDI-Device Identifier: 10705031056824
• UDI-Public: 10705031056824
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: VCPP40D
• Device Catalogue Number: VCPP40D
• Device Lot Number: QKMMCK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1